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A randomized controlled trial of telephone-delivered cognitive behavioral therapy, modafinil, and combination therapy of both interventions for fatigue in multiple sclerosis
Investigator (PI): Braley, Tiffany; Kratz, Anna
Performing Organization (PO): (Current): University of Michigan, Michigan Medicine, Department of Neurology / (734) 936-9010
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/MS-1610-36980
Funding: Total Award Amount: $3,156,833
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Many individuals with multiple sclerosis (MS) suffer from fatigue, which is often their most disabling symptom. Treatments for MS fatigue are limited, so it is important to maximize the effectiveness of available therapies, which should include tailoring the treatment to the individual. Unfortunately, health care providers have little information to help guide them when they are creating a fatigue treatment program for a patient with MS and fatigue. For example, providers have little information to help them decide whether a single therapy, such as a medication or behavioral therapy, will be enough for a given patient, or whether therapies should be combined to provide the best results. This clinical trial, which will be guided by feedback from MS patients, MS providers, community organizations, and payers, will compare the effectiveness of a commonly used behavioral treatment strategy (cognitive behavioral therapy), a commonly used medication (modafinil), and a combination of both therapies for fatigue in a large, representative group of patients with MS. Fatigue will be measured with a combination of patient centered survey measures as well as measures of physical activity and fatigue, which will be collected with a wrist-worn device as study participants go about their day. These measures will open a window into the day-to-day experiences of patients with MS, before and after treatment. The effects of other conditions and problems that are common in MS (depression, sleep disturbances, and disability), on response to each of the different treatments will also be assessed, which will be particularly helpful in terms of giving providers more information on how to tailor fatigue intervention plans to patients' individual circumstances and needs. Other factors related to the patient experience with these different treatments, such as how well people in each treatment condition followed the treatment program ("treatment adherence") and whether patients experienced any negative side effects. Results of this study will help patients, providers, and policy makers determine which patients with fatigue respond best to cognitive behavioral therapy or modafinil, and which MS patients may benefit most from a combination of these treatments.
MeSH Terms:
  • Benzhydryl Compounds /*pharmacology
  • Cognitive Behavioral Therapy /*methods
  • Combined Modality Therapy
  • Comparative Effectiveness Research
  • Exercise
  • Fatigue
  • Health Policy
  • Humans
  • Multiple Sclerosis /*drug therapy
  • /*psychology
  • Outcome Assessment (Health Care)
  • Patient-Centered Care /organization & administration
  • Randomized Controlled Trials as Topic
  • Surveys and Questionnaires
  • Telemedicine /*methods
  • Wakefulness-Promoting Agents /*pharmacology
Country: United States
State: Michigan
Zip Code: 48109
UI: 20181647
Project Status: Ongoing
Record History: ('2018: Project initial year changed to 2018 and final year extended to 2022.',)